CLASS II ONGOING Drug recall · Reported 12 Apr 2023 · FDA Enforcement Report
Alprazolam C-IV, 1 mg recalled by Direct Rx
Direct Rx is recalling Alprazolam C-IV, 1 mg, distributed nationwide in the US. The recall was initiated on 22 Mar 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0508-2023
- FDA event ID
- 92054
- Recalling firm
- Direct Rx, Dawsonville, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Mar 2023
- FDA classified
- 6 Apr 2023
- Reported
- 12 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Anxiety & Sleep Medication
Timeline
| 22 Mar 2023 | Recall initiated by company | |
| 6 Apr 2023 | Classified by FDA | +15 days |
| 12 Apr 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Product as listed by the FDA
Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Alprazolam C-IV, 1 mg recalled?
Yes. Direct Rx recalled Alprazolam C-IV, 1 mg on 22 Mar 2023. The recall is Class II and its status is Ongoing. Recall number D-0508-2023.
Why was it recalled?
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Which lots are affected?
Lots: a) 03FE2318, Exp. 8/31/24; b) 27FE2315, 28FE2313, 02MA2306, 21SE2201, 16NO2216, 17NO2216, 24FA2314, Exp. 8/31/24; 17FE2203, 12AP2204, 17MA2205, Exp. 3/31/23; 21JU2206, 22JU2220, 12JY2206, Exp. 5/31/23; 10AU2209, Exp. 6/30/23; 14DE2215, Exp. 9/30/24; 05JA2304, 27JA2301, Exp. 11/30/24.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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